September 22, 1978 
Dr. Donald S. Fredrickson 
Director 
National Institutes of Health 
Bethesda, MD 
Dear Dr. Fredrickson: 
I am writing to indicate my overall support for the PRG-NIH as published 
in the Federal Register, Volume 43, Number 146, July 28, 1978. As a 
scientist involved in recombinant DNA research, I have continually sup- 
ported the concept of NIH promulgated guidelines. The proposed NIH 
revisions to the current guidelines are generally very well reasoned 
and clearly reflect the substantial body of new knowledge acquired over 
the last several years, as well as the recognition by those formulating 
policy of a large body of information relating to epidemiology and 
infectious disease. 
While generally in support of the PRG-NIH, I do wish to offer several 
comments which I feel merit consideration. 
1. Section I-E-3 (page 33070, column II, paragraph 5) exempts from the 
PRG-NIH recombinant DNA molecules consisting entirely of DNA from a 
prokaryotic host, including indigenous (emphasis added) plasmids or 
viruses when propagated in that host (or closely related strain of the 
same species). Your Decision of the Director, dated July 19, 1975, 
page 33050, paragraph 4, indicates indigenous to mean "found in 
Nature." I would like to suggest that, if a plasmid from one strain 
or species can be transferred to another strain or species in the 
laboratory, then recombinant DNA experiments involving that second 
host and plasmid should also be exempt from the guidelines. Foot- 
note 35, page 33088, to section III-B-2, page 33080, indicates that 
plasmid transfer may be less stringent a definition than applied 
to section I-E-4. However, since I-E-4 pertains to interspecies 
recombination, and I-E-3 applies to "self-cloning," it seems reason- 
able that "self-cloning" with plasmids transferred in the laboratory 
by natural genetic processes such as conjugation are clearly consis- 
tent with the intent of the PRG-NIH and pose no conceivable risk to 
the investigator or the environment. 
2. On page 33096, as part of the Summary of the NIH-EIA . . . under "Envi- 
ronmental Impact of Proposed Action," you use the term "conjectural 
hazards." To the extent possible, I feel the terms "conjectural" or 
"speculative," rather them "potential," are preferred adjectives to 
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